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FDA 510(k)

WRIGHT 1000 MONOPLACE HYPERBARIC SYSTEM

K-Number: K952545 · 1997-05-28

ApplicantWright Industries
Decision Date1997-05-28
Product CodeCBF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

WRIGHT 1000 MONOPLACE HYPERBARIC SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Wright Industries. It received FDA 510(k) clearance on 1997-05-28 under 510(k) number K952545. The device is classified under product code CBF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WRIGHT 1000 MONOPLACE HYPERBARIC SYSTEM?

WRIGHT 1000 MONOPLACE HYPERBARIC SYSTEM is a medical device that received FDA 510(k) clearance on 1997-05-28. The listed applicant is Wright Industries. The 510(k) number is K952545.

When did WRIGHT 1000 MONOPLACE HYPERBARIC SYSTEM receive FDA 510(k) clearance?

WRIGHT 1000 MONOPLACE HYPERBARIC SYSTEM received FDA 510(k) clearance on 1997-05-28, under 510(k) number K952545.

Who is the listed applicant for WRIGHT 1000 MONOPLACE HYPERBARIC SYSTEM?

The FDA 510(k) record lists Wright Industries as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WRIGHT 1000 MONOPLACE HYPERBARIC SYSTEM?

The FDA product code for WRIGHT 1000 MONOPLACE HYPERBARIC SYSTEM is CBF.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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